Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes

Completed

• Conditions: Young Adults; Adolescents; Type1 Diabetes
• Interventions: Device: Hybrid closed loop (HCL)

• Registration Number: NCT06253351
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief Summary

The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

Detailed Description

Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.

For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.

Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.

At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Study Start: 2024-03-13
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Patient aged between 15 and 25 years old
• Type 1 diabetes since at least 1 year at the moment of instauring HCL
• At least 3 months of HCL use

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Exclusion Criteria

• Informed patient that have been opposed for their data collect

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	Hybrid closed loop (HCL)	Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop

Primary Outcome Measures

Name	Time	Method
HbA1c after HCL	at 3 months	Comparison of HbA1c (%) before and after HCL (at least 3 months of use)

Secondary Outcome Measures

Name	Time	Method
keto-acidosis and severe hypoglycemia	at 3 months	Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL
Use of HCL	at 3 months	Percentage of use of HCL
Glycemic parameters with CGM	at 3 months	pourcentage Coefficient of Variation (CV)
retinopathy	at 3 months	Comparison of retinography results before HCL and after HCL
nephropathy	at 3 months	Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL
HbA1c after HCL	at 24 months	Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
HCL stop	at 3 months	number of HCL stop

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France